Abbott Secures CE Mark for Volt Pulsed Field Ablation System, Joining European Market Race

Abbott has received European approval for its Volt pulsed field ablation (PFA) system, marking the company's entry into the competitive atrial fibrillation treatment market in Europe. The CE mark, granted earlier than anticipated, allows Abbott to join established players such as Boston Scientific, Medtronic, and Johnson & Johnson in offering PFA technology to European healthcare providers.

Abbott's Volt System: Advancing PFA Technology

The Volt system aims to address limitations of current PFA platforms by incorporating features designed to enhance procedural efficiency and effectiveness. Key innovations include:

• A balloon-in-basket design for single-shot ablations
• Integration with Abbott's EnSite X 3D mapping system for real-time feedback
• Improved tissue contact detection capabilities

Christopher Piorkowski, Chief Medical Officer of Abbott's electrophysiology business, emphasized the system's design improvements, stating, "We've incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient."

Clinical data supporting the Volt system's efficacy demonstrates the ability to achieve pulmonary vein isolations with fewer ablation attempts compared to existing technologies.

European Market Landscape and Commercial Rollout

Abbott's entry into the European PFA market follows several competitors:

• Boston Scientific's Farapulse system (CE mark in early 2021)
• Medtronic's Affera system and Sphere-9 catheter (CE mark in March 2023)
• Johnson & Johnson's Varipulse hardware (CE mark in February 2024)

Abbott has already begun commercial cases in Austria, Germany, Belgium, and the Netherlands, involving physicians who participated in the Volt system's clinical studies. The company plans to expand its rollout across the European Union in the latter half of 2025.

With an estimated 8 million people over 65 diagnosed with atrial fibrillation in Europe, and projections suggesting this number could double in the next 30 years, the market for advanced treatment options like PFA is poised for significant growth.

Competitive Landscape and Recent Developments

As Abbott enters the European PFA market, its competitors continue to advance their own technologies:

• Boston Scientific recently received European approval for its updated Farawave Nav catheter, which incorporates integrated mapping capabilities.
• Medtronic and Johnson & Johnson have established presences in the market with their respective systems.

The rapid development and approval of PFA systems across multiple manufacturers underscore the growing importance of this technology in treating atrial fibrillation. As companies refine their offerings and expand market presence, healthcare providers and patients stand to benefit from increased treatment options and potential improvements in procedural outcomes.